For Patients

Ablavar (gadofosveset trisodium) Injection is a contrast agent used in combination with magnetic resonance angiography (MRA) to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on the MRA. It is used to help diagnose certain disorders of the heart and blood vessels. Common side effects include itching; headache; dizziness; nausea, unusual or unpleasant taste in your mouth; warmth, redness, burning, or tingly feeling under your skin; cold feeling, warmth, pain, bruising, or burning where the injection was given; or numbness or tingling in your hands or feet.

Ablavar is given as an intravenous bolus injection, manually or by power injection, at a dose of 0.12 mL/kg body weight (0.03 mmol/kg) over a period of time up to 30 seconds followed by a 25-30 mL normal saline flush. Ablavar may interact with other drugs that can harm the kidneys. Tell your doctor all medications and supplements you use. It is unknown if Ablavar will harm a fetus. Before you receive this medication, tell your doctor if you are pregnant. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Ablavar (gadofosveset trisodium) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Because clinical studies are conducted under widely
varying conditions, adverse reaction rates observed in the clinical studies of
a drug cannot be directly compared to rates in the clinical studies of another
drug and may not reflect the rates observed in practice.

Clinical Studies Experience

Anaphylaxis and anaphylactoid reactions were the most
common serious reactions observed following ABLAVAR injection administration [see
WARNINGS AND PRECAUTIONS].

In all clinical trials evaluating ABLAVAR with MRA, a
total of 1,676 (1379 patients and 297 healthy subjects) were exposed to various
doses ABLAVAR. The mean age of the 1379 patients who received ABLAVAR was 63
years (range 18 to 91 years); 66% (903) were men and 34% (476) were women. In
this population, there were 80% (1100) Caucasian, 8% (107) Black, 12% (159)
Hispanic, 1% (7) Asian, and < 1% (6) patients of other racial or ethnic
groups. Table 2 shows the most common adverse reactions ( ≥ 1%) experienced
by subjects receiving ABLAVAR at a dose of 0.03 mmol/kg.

Post-marketing Experience

Because post-marketing reactions are reported voluntarily
from a population of uncertain size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to drug exposure.
The profile of adverse reactions identified during the post-marketing experience
outside the United States was similar to that observed during the clinical
studies experience.